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Neural Components Underlying the Treatment of Adolescent Depression

This study is currently recruiting participants.
Verified March 2016 by Randy P. Auerbach, Mclean Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717508
First Posted: October 30, 2012
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Randy P. Auerbach, Mclean Hospital
  Purpose

The goal of the study is to examine how cognitive behavioral therapy (CBT), a common treatment for adolescent depression, affects brain functioning. Depressed adolescents will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. EEG (electroencephalography) measures brain activity by recording the electrical activity along the scalp caused by the firing of neurons within the brain. They will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long and held once a week for 12 weeks. Before their third therapy session, participants will complete a computer task while EEG data are recorded. After completing the treatment, the participants will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1, 3, and 6 months after completing the treatment.

This study will also include healthy control participants. They will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. Three weeks later, they will return to complete a behavioral task while EEG data are recorded. Twelve weeks after the initial assessment, they will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording.


Condition Intervention
Major Depressive Disorder Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression

Further study details as provided by Randy P. Auerbach, Mclean Hospital:

Primary Outcome Measures:
  • EEG Activity [ Time Frame: 12 weeks ]
    EEG and ERP measures collected during resting state and behavioral tasks


Estimated Enrollment: 112
Study Start Date: October 2012
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cognitive Behavioral Therapy
12 weekly sessions of cognitive behavioral therapy
Behavioral: Cognitive Behavioral Therapy
12 sessions of cognitive behavioral therapy
No Intervention: Healthy Controls

Detailed Description:
The purpose of the study is to examine the impact of individual cognitive behavioral therapy (CBT) for adolescent depression on neural functioning. Specifically, the study will utilize Brent and Poling's (1997) cognitive behavioral therapy (CBT) manual (Cognitive Therapy Treatment Manual for Depressed and Suicidal Youth), and investigators will examine pre- to post- neural activity patterns for children and adolescents who receive individual CBT for depression. Electroencephalography (EEG) techniques will be utilized to assess treatment-related effects on brain activity (i.e., anterior cingulate cortex and dorsolateral prefrontal cortex functioning). Neural activity patterns will also be compared to non-depressed, healthy controls.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria, Major Depressive Disorder Participants:

  • Ages 13-18 years at time of initial assessment
  • Female
  • Current major depressive disorder (MDD) diagnosed according to the K-SADS Axis I semi-structured interview
  • English as first language or English fluency

Exclusion Criteria, Major Depressive Disorder Participants:

  • Male
  • Mania/Hypomania
  • Current anxiety disorders [e.g., Panic Disorder (PD), Generalized Anxiety Disorder (GAD), Obsessive Compulsive Disorder (OCD)]
  • Eating Disorders
  • Substance Abuse/Dependency
  • Conduct Disorder/Antisocial Disorder
  • ADHD
  • Psychosis
  • Mental Retardation
  • Organic Brain Syndrome
  • Current Psychotherapy Treatment
  • Medical & neurological illness (head injury, loss of consciousness for more than 5 minutes, seizures)
  • Current use of psychotropic medication for treatment of MDD with the exception of SSRIs (selective serotonin reuptake inhibitors)
  • Active suicidality

Inclusion Criteria, Healthy Control Participants:

  • Ages 13-18 years at time of initial assessment
  • Female
  • English as first language or English fluency

Exclusion Criteria, Healthy Control Participants (in addition to the exclusion criteria of the MDD group):

  • Elevated depressive symptoms as assessed in phone screen
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717508


Contacts
Contact: Colin Stanton 617-855-4240 camdl@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Colin Stanton    617-855-4240    camdl@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Randy P Auerbach, PhD Mclean Hospital
  More Information

Responsible Party: Randy P. Auerbach, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01717508     History of Changes
Other Study ID Numbers: 2012P001844
2011A053424 ( Other Grant/Funding Number: Harvard Medical School )
2011A051965 ( Other Grant/Funding Number: McLean Hospital )
2010A054978 ( Other Grant/Funding Number: Katz Family Foundation )
K23MH097786 ( U.S. NIH Grant/Contract )
First Submitted: October 23, 2012
First Posted: October 30, 2012
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Randy P. Auerbach, Mclean Hospital:
MDD
depression
major depressive disorder
adolescent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders